Phase 3
Completed N=325
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Source: ClinicalTrials.gov NCT00770692 ↗Enrolled (actual)
325
Serious AEs
3.1%
Results posted
Nov 2012
Primary outcomePrimary: Incidence of Adverse Events — 81.5; 79.5; 82.1; 87.0 Percentage of Participants
Summary
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
81.5; 79.5; 82.1; 87.0 | — |
| SECONDARY Mean Change From Baseline In Sleep Latency |
65.5; 70.7; 71.8; 64.0; -32.1; -37.0 | — |
| SECONDARY Mean Change From Baseline in Wake Time After Sleep Onset (WASO) |
61.6; 68.8; 53.2; 42.3; -30.8; -35.1 | — |
| SECONDARY Mean Change From Baseline in Total Sleep Time |
314.2; 307.9; 290.7; 308.2; 63.6; 74.2 | — |
| SECONDARY Mean Change From Baseline in Total Number of Awakenings |
1.8; 1.9; 1.7; 1.6; -0.5; -0.5 | — |
Eligibility Criteria
Inclusion criteria
- Participants who submit written informed consent for study entry.
- Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
- Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version or diagnosed with insomnia associated with psychiatric or physical disorder(s).
- Participants with both of the following conditions which are persistent for 4 weeks or longer before the start of observation period:
- Total sleep time is less than or equal to 390 minutes for more than or equal to 3 days a week
- Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week
- Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:
- Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
- Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week
Exclusion criteria
- Participants with a present or history of the following disease specified in
Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0:
- Risk of suicide
- (Mild) manic episode
- Post-traumatic stress disorder (PTSD)
- Alcohol dependence and abuse
- Drug (non-alcohol) dependence and abuse
- Anorexia nervosa
- Bulimia nervosa
- Anti-social personality disorder
- Participants with pharmacologically induced insomnia (drug-induced insomnia).
- Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.
- Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.
- Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
- Participants with organic mental disorder.
Data sourced from ClinicalTrials.gov (NCT00770692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.